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A new drug designed for the therapy of neuroendocrine tumors has received approval
Last reviewed: 02.07.2025
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FDA – American Food and Drug Administration, - recommended for use the drug Lutathera (Lutetia 177Lu), which is intended for the treatment of neuroendocrine tumor processes in the digestive system. This type of radiopharmaceutical drug is approved for the first time: it is planned to be used as a drug for adult patients diagnosed with neuroendocrine tumors of the digestive organs, with expression of the somatostatin receptor apparatus.
We are talking about the newest radiopharmaceutical drug, the therapeutic effect of which is due to the interaction with the receptor mechanism of somatostatin, localized on the cellular structures of the tumor. After binding to the receptor mechanism, the drug enters the tumor cellular structures, damaging them from the inside.
The FDA recommended the new drug after evaluating the results of two research projects.
The first clinical randomized testing involved more than two hundred patients suffering from different types of neuroendocrine oncology of the digestive organs, with expression of the somatostatin receptor apparatus. Patients were offered a combination of the new drug and octreotide, or only octreotide. The percentage of survival with subsequent positive dynamics was found in patients who were treated with a combination of the new drug with octreotide. Among those patients who did not take Lutathera, survival was lower, and the disease continued to progress to one degree or another. Scientists concluded that the participants in the first group had a much lower risk of death or further development of the tumor process, compared with the participants in the second group.
The next experiment involved more than 1,200 patients diagnosed with neuroendocrine neoplasms of the digestive system, with expression of somatostatin receptors. According to the results, a noticeable decrease in the size of the pathological formation was recorded in 16% of cancer patients.
Of course, the scientists also described possible side effects during treatment with the newest drug. Among the common manifestations, lymphopenia, increased levels of individual enzymes (ALT, AST, GGT), dyspepsia, hypokalemia, and hyperglycemia were recorded.
Among the serious side effects, myelosuppressive conditions, development of secondary myelodysplastic syndrome and leukemia, liver and kidney damage, reproductive dysfunction, hormonal disorders should be especially highlighted.
Lutathera is definitely not suitable for treating pregnant women. In addition, patients who are treated with the new drug are exposed to radiation. Therefore, they will have to limit contact with other people during the therapeutic course, including relatives and medical personnel. This is implied by radiation safety rules.
Material provided by FDA.gov
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